Berlex Laboratories Inc., a subsidiary of Germany-based ScheringAG, turned up the heat in its fight against Biogen Inc.'s multiplesclerosis drug, Avonex, by filing a federal lawsuit last week allegingpatent infringement.

The complaint, filed in the U.S. District Court in Newark, N.J.,alleged Avonex, or interferon-beta 1a, violated a Berlex patent,issued in the U.S. in December 1994, covering recombinant DNAproduction of the beta interferon protein in Chinese hamster ovarycells.

Biogen received FDA approval to market Avonex May 17, 1996, forrelapsing and remitting multiple sclerosis and started selling it threedays later.

Berlex, of Wayne, N.J., and its parent company, Berlin-basedSchering, have the only other drug on the U.S. market for the sameindication. The companies' Betaseron, or interferon-beta 1b, ismanufactured by Chiron Corp., of Emeryville, Calif., and was clearedby the FDA in 1993.

The patent infringement battle does not involve Betaseron, which isproduced in Escherichia coli, not mammalian cells.

Biogen, of Cambridge, Mass., in a prepared statement last week, saidit anticipated the Berlex court action and filed a lawsuit in U.S.District Court in Boston May 3, 1996, seeking a judgment that theBerlex patent (5,376,567) is invalid and not infringed by Avonex.

Biogen called the Berlex complaint "completely without merit andanother desperate attempt to keep Avonex off the market."

In April 1996, Berlex sued the FDA in U.S. District Court inWashington to stop the agency from approving Avonex, sayingmarket clearance would violate Betaseron's orphan drug status andother FDA procedures. (See BioWorld Today, April 29, 1996, p. 1.)

The court in early May 1996 rejected Berlex's request for atemporary restraining order against the FDA, but said the companycould pursue its complaint after the agency acted on Avonex. Lastweek the FDA asked the court to dismiss Berlex's lawsuit.

Biogen officials said Monday they will file court papers in support ofthe FDA motion.

Berlex released news of its patent infringement lawsuit Wednesdayand Biogen's stock (NASDAQ:BGEN) fell $1.25 to $54.25. Biogenended Friday down another 50 cents to $53.75. It closed Mondaydown $1 to $52.75.

Multiple sclerosis is a degenerative inflammatory disease thatdisrupts the brain's nerve impulses and interferes with movement,speech, vision and memory. About 50 percent of the 250,000 peoplein the U.S. with the disorder suffer from a relapsing and remittingform of the disease. The others experience a steady decline towardparalysis with few remission periods.

Neither Avonex nor Betaseron is a cure. However, Avonex hasdemonstrated it can slow progression of the disease and reduce flare-ups. Betaseron showed it could reduce relapses, but fell short ofproving it could slow the disorder's deteriorating march.

Betaseron has annual U.S. sales of $225 million. It is not on themarket in Europe.

Avonex, analysts said, is expected to generate more than $300million in revenues for Biogen in the U.S. and Europe during 1997.The company expects to begin marketing in Europe in the firstquarter of next year. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.